NCT06052475: PROTECT-UP

Physiological Versus Right Ventricular Outcome Trial Evaluated for Bradycardia Treatment Upgrades

Recruiting now NA Last updated 19 September 2024

What this trial tests

NA trial testing Physiological Pacing Upgrade (Conduction System Pacing or Biventricular Pacing) in Pacing-Induced Cardiomyopathy in 155 participants. Currently enrolling.

Timeline

25 September 2023

Primary endpoint
1 May 2026

31 August 2026

Quick facts

Lead sponsor	Imperial College London
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	155
Start date	25 September 2023
Primary completion	1 May 2026
Estimated completion	31 August 2026
Sites	12 locations across United Kingdom

Drugs / interventions tested

• Physiological Pacing Upgrade (Conduction System Pacing or Biventricular Pacing)
• Continued RV Pacing (Right Ventricular Pacing)

Conditions studied

• Pacing-Induced Cardiomyopathy — all drugs for Pacing-Induced Cardiomyopathy →
• Heart Failure — all drugs for Heart Failure →

Sponsor

Imperial College London

Who can join

18 and older, any sex, with Pacing-Induced Cardiomyopathy or Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Guidelines for patients having first-time implants advocate that even when heart function is only mildly impaired, modern pacing approaches should be utilised to avoid the potentially damaging effects of RV pacing to preventing symptoms from pacing induced or worsened cardiomyopathy.

However, once a traditional (RV) pacemaker is implanted, development of impaired heart function does not prompt a device upgrade. Even at the end of battery life, physicians simply replace it like-for-like.

This trial tests whether such patients have better symptoms and quality of life if changed to a modern physiological pacing strategy from the traditional RV pacing approach.

In this crossover trial, participants will be upgraded to a physiological pacing strategy.

After their procedure, they will have a one-month run-in period to recover from the procedure (their pacemaker will be programmed to continued RV pacing).

They will be have 2 one-month blinded time periods, randomised to physiological pacing or right ventricular pacing alternately. They will subsequently undergo two six-month blinded randomised time periods.

Patients will document symptoms monthly on a mobile phone application or computer. At the end of each time period, they will have measurements of heart function, a walking test and quality-of-life questionnaires including the SF-36 questionnaire.

The investigators hypothesise that upgrading to physiological pacing strategies will improve patients' quality of life.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. European Society of Cardiology (ESC) clinical consensus statement on indications for conduction system pacing, with special contribution of the European Heart Rhythm Association of the ESC and endorsed by the Asia Pacific Heart Rhythm Society, the Canadian Heart Rhythm Society, t
   Glikson M, Burri H, Abdin A, Cano O, et al · · 2025 · cited 67× · PMID 40159278 · DOI 10.1093/europace/euaf050
2. Is Conduction System Pacing a Valuable Alternative to Biventricular Pacing for Cardiac Resynchronization Therapy?
   Castagno D, Zanon F, Pastore G, De Ferrari GM, et al · · 2024 · cited 2× · PMID 38786966 · DOI 10.3390/jcdd11050144
3. Cardiac implantable electronic device upgrades and downgrades: a Clinical Consensus Statement of the European Heart Rhythm Association (EHRA) of the ESC, the Asia Pacific Heart Rhythm Association (APHRS), Canadian Heart Rhythm Society (CHRS), Heart Rhythm Society (HRS), and the L
   Keene D, Nielsen JC, Nielsen JC, Burri H, et al · · 2025 · cited 1× · PMID 41378985 · DOI 10.1093/europace/euaf252